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Cleanroom Pyrogen Sources: Gloves, Wipes, and People

  • 2021-08-26 14:36:47

Cleanroom Pyrogen Sources: Gloves, Wipes, and People


A cleanroom wipe or wiper is an essential process tool for nearly every controlled manufacturing operation. Novel wipe materials allow repeatable cleaning among abrasive or delicate surfaces without introducing chemicals, fibers, particulates, or viruses and bacteria onto products, surfaces, and even people.


Studies show that bare hands and non-endotoxin free gloves yield higher endotoxin loading than samples collected wearing endotoxin-free gloves.


“Samples collected using cloths with bare washed hands yielded higher endotoxin loading per mass of collected dust versus samples collected wearing endotoxin-free gloves. This demonstrated additional endotoxin loading from the subject’s hand.”


Occupational and Environmental Health, College of Public Health, The University of Iowa

One must consider the use of wipes low in endotoxins, but also low endotoxin gloves. Glove-induced endotoxins may indicate positive results when transferred to contact sources.



Gram-negative Bacteria



Problematically, Gram-negative bacteria are highly resistant to common cleanroom disinfection techniques such as 70% isopropyl alcohol. Heat, autoclave, and gamma sterilization are the most common sterilization techniques uses in cleanrooms.

Pseudomonas (e.g., P. aeruginosa) are the most frequent isolates from contaminated disinfectants—recovered from 80% of contaminated products. Their ability to remain viable or grow in use-dilutions of disinfectants is unparalleled.

Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)

Wipe Sterilization Methods

  1. Wet steam autoclaving
  2. Electron Beam
  3. Steam Autoclaving

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